Diabetic kidney disease (DKD) is a leading cause of chronic kidney disease worldwide and diabetes predisposes patients to pruritus. Anrikefon is a novel selective peripherally restricted kappa-opioid receptor agonist. This post hoc analysis utilized data from phase 3 anrikefon-302 study to investigate the efficacy and safety of anrikefon in the treatment of diabetic hemodialysis patients with pruritus. This is a post hoc analysis of data collected in a randomized, placebo-controlled phase 3 study. Diabetic hemodialysis patients were included (anrikefon n = 67 and placebo n = 79). The percentage of patients achieving at least a 4-point or 3-point reduction in weekly mean 24 hour worst itching intensity numerical rating scale (WI-NRS) score from baseline to week 12 were analyzed. The changes in itch related quality of life from baseline using the Skindex-10 and 5-D itch scales were also compared. The baseline demographics and characteristics were generally similar in the individual placebo and anrikefon treatment arms. Interestingly, significantly more patients reported a clinically meaningful ≥ 4-point (29.9

Background Chronic kidney disease-associated pruritus (CKD-aP) is a common and distressing symptom in hemodialysis patients. This Phase II trial evaluated the efficacy and safety of HSK21542, a selective kappa-opioid receptor agonist, in managing CKD-aP.Methods Adult patients on hemodialysis with moderate to severe pruritus, were randomized 1:1:1 to placebo, or HSK21542 (0.3 mu g/kg or 0.6 mu g/kg) administered thrice weekly post-dialysis for 12 weeks. The primary endpoint was the change from baseline in the weekly mean of the worst itching intensity Numerical Rating Scale (WI-NRS) score at week 12. Secondary endpoints included quality-of-life assessments, safety evaluations, and pharmacokinetic properties.Results A total of 90 patients were enrolled. At week 12, mean changes in WI-NRS scores from baseline were -2.94 for the placebo group, -3.40 for the 0.3 mu g/kg HSK21542 group, and -2.21 for the 0.6 mu g/kg HSK21542 group. The percentages of patients who had a reduction of 3 points or above in their WI - NRS scores were 44.4% in the placebo group, 62.1% in the 0.3 mu g/kg HSK21542 group, and 37.0% in the 0.6 mu g/kg HSK21542 group. The 0.30 mu g/kg HSK21542 group demonstrated more significant improvements in Skindex - 16 scores compared to the placebo. The 5-D Itch Scale scores also presented similar trends. Both the 0.3 mu g/kg and 0.6 mu g/kg doses of HSK21542 were well - tolerated, with no dose-dependent adverse effects.Conclusion The 0.3 mu g/kg dose of HSK21542 demonstrated superior efficacy and safety in reducing pruritus and improving quality of life in hemodialysis patients.

Background: Ipsilateral subclavian vein stenosis in a well-functioning upper extremity arteriovenous fistula (AVF) is a significant factor contributing to AVF failure and sometimes swelling of ipsilateral upper extremity. Graft bypass surgery can alleviate outflow tract stenosis in upper extremity AVF, restore function, and efficiently relieve arm swelling. The present study aimed to evaluate patency and postoperative complications after cephalic to jugular graft bypass surgery in patients with upper extremity AVF failure or upper extremity swelling on the same side of the AVF resulting from ipsilateral subclavian vein stenosis. Methods: Five patients with upper extremity AVF and ipsilateral subclavian vein stenosis undergoing maintenance hemodialysis were included. Three patients had AVF dysfunction, while two experienced swelling of the arm due to high venous pressure in the AVF. The surgical procedure involved creating a subcutaneous tunnel in the shoulder to connect a 6 mm polytetrafluorethylene (PTFE) graft, from either near the fistula site ( n = 3) or at the mid-upper arm cephalic vein ( n = 2), to the jugular vein. Results: Graft bypass surgery was successful, and all patients were able to resume hemodialysis postoperatively. Upper extremity edema improved, without any postoperative wound infections, non-healing wounds, steal syndrome, or high-flow AVF leading to heart failure as a complication. Five to 19 months after surgery, the bypass grafts exhibited a primary patency rate of 100%, and vascular access fulfilled the requirements for hemodialysis. Conclusions: Cephalic to jugular vein bypass surgery for upper extremity AVF with ipsilateral subclavian vein stenosis effectively preserved function of the original fistula, and was associated with few postoperative complications.

Background: HSK21542, a novel selective peripherally-restricted κ-opioid receptor agonist has been proven to be a safe and effective analgesic and antipruritic drug in both in vitro and in vivo studies. We aimed to evaluate its safety, pharmacokinetics and efficacy in hemodialysis patients over a 1-week treatment period, and to establish the optimal dosage for a further 12-week stage 2 trial.Methods: In this multiple ascending dose study, hemodialysis patients were randomly assigned to receive HSK21542 (0.05–0.80 μg/kg), or a placebo three times within 2.5 h at the end of each dialysis session for 1 week. Safety evaluations included reports of treatment-emergent adverse events (TEAEs); pharmacokinetics and efficacy outcomes were also assessed.Results: Among the 44 screened patients, 41 were enrolled and completed the trial. The overall incidence of TEAEs was higher in the HSK21542 group compared to the placebo group, with an incidence of 75.0%, 50.0%, 75.0%, and 88.9% in the range of 0.05–0.80 μg/kg. All TEAEs were grade 1 or 2 in severity. HSK21542 exhibited linear pharmacokinetics characteristics within the dose range 0.05–0.80 μg/kg, without drug accumulation after multiple-doses. Compared to the placebo, a significant decrease of the weekly mean Worst Itching Intensity Numerical Rating Scale was found in the HSK21542-0.30 μg/kg group (p = 0.046), but without significant improvement in the Skindex-16 score.Conclusion: HSK21542 was well tolerated in the dose range 0.05–0.80 μg/kg in hemodialysis patients. HSK21542-0.3 μg/kg exhibited promising efficacy in patients with moderate to severe pruritus and warrants a further Stage 2 trial.Clinical Trial Registration:https://clinicaltrials.gov/, identifier NCT04470154.

The global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had a catastrophic impact on human life and economic life. Due to the combination of multiple underlying diseases and low vaccination rates, dialysis patients are susceptible to SARS-CoV-2 infection and are likely to have more severe illness and even death. Moreover, dialysis patients with SARS-CoV-2 infection may initially present as asymptomatic or with mild symptoms, which makes it very difficult to identify severe patients at an early stage. Here, the epidemiology, clinical characteristics, risk factors for prognosis, vaccination and therapeutic strategies of dialysis patients with SARS-CoV-2 infection were summarized and analyzed, and it is hoped to provide a reference for the diagnosis and treatment of SARS-CoV-2 infection in this special group of patients.

Background: Protein-energy wasting (PEW) and inflammation have been recognized as two major factors associated with the poor prognosis of patients with maintenance haemodialysis (MHD). The aim of this study was to evaluate the effects of oral fat based high-energy supplements (Fresubin) on malnutrition and inflammation in MHD patients. Method: This study was open-label, prospective, nonrandomized and comparative. A total of 47 MHD patients with PEW were randomly assigned into 2 groups: a control group, and a Fresubin treatment group, in which patients received daily diet intake and Fresubin nutrient support 120 mL/d for 80 days. Laboratory data and anthropometric parameters were measured. Result: The results showed that compared with baseline, the level of serum albumin at 80 d in the Fresubin treatment group was significantly increased (35.4 ± 3.7 vs 38.9 ± 2.9, p = 0.003), while there was no significant difference in the control group. In addition, the magnitudes of changes in albumin (p = 0.009), serum prealbumin (p = 0.017), and abdominal circumference (p = 0.037) in the Fresubin treatment group were markedly increased compared with those in the control group. There was a downward trend in the inflammatory marker hypersensitive C-reactive protein in the Fresubin group (p =0.056), which decreased more dramatically than that in the control group (p = 0.026). Conclusion: Fresubin treatment is well tolerated, and improves malnutrition and inflammatory status in MHD patients with PEW.

BACKGROUND:The treatment of acute pancreatitis (AP) induced by hypertriglyceridemia (HTG) remains controversial with regard to plasmapheresis vs conventional treatment. We reviewed relevant articles to explore the efficacy of plasmapheresis in the management of HTG-induced AP. METHODS:We systematically reviewed studies that compared plasmapheresis with conventional treatment for HTG-induced AP using three databases: PubMed, Embase, and Cochrane Library, as well as relevant references. The primary outcomes were 24 h triglyceride reduction rate and in-hospital mortality. RESULTS:A total of 791 articles were retrieved. Finally, 15 observational studies (1080 participants) were included, most of which were historical cohort studies. Compared with conventional treatment, plasmapheresis assisted in the reduction of serum triglyceride (TG) levels in the first 24 h after hospital admission (standardized mean difference [SMD]: 0.58; 95% confidence interval [CI]: 0.17 to 0.99; P = 0.005). However, it resulted in increased hospitalization costs (thousand yuan) (weighted mean difference [WMD]: 24.32; 95% CI: 12.96 to 35.68; P < 0.001). With regard to in-hospital mortality, although the mortality rate in the plasmapheresis group was higher than that in the conventional treatment group (relative risk [RR]: 1.74; 95% CI: 1.03 to 2.94; P = 0.038), the result was disturbed by confounding factors as per the subgroup and sensitivity analysis, as well as trial sequential analysis (TSA). No significant differences were found in other outcomes, including systematic complications, local complications, the requirement for surgery, and hospitalization duration. CONCLUSION:The effect of plasmapheresis in HTG-induced AP is not superior to that of conventional treatment, even resulting in a greater economic burden to patients and health care system. High quality randomized control trials are required to obtain a more a definitive understanding of this issue.

Introduction Osteoporosis is one of the important bone abnormalities in chronic kidney disease-mineral and bone disorder (CKD-MBD) and still lacks a sensitive biomarker to diagnose. Fibroblast growth factor 21 (FGF21) can stimulate bone loss in patients with diabetes and increase in CKD patients. In this study, we investigated whether FGF21 could serve as a biomarker to predict osteoporosis in a haemodialysis cohort. Methods We recorded demographic information, biochemical data, and serum FGF21 and FGF23 levels and measured the CT attenuation values of 339 haemodialysis patients from two large medical centres. We assessed the correlation of CT attenuation values with serum FGF21 and FGF23 levels and tested whether they were independent factors for osteoporosis. ROC curves were constructed to compare the prognostic value of FGF21 and FGF23 for osteoporosis. Results Based on the CT attenuation value, serum FGF21 levels were higher in our osteoporosis group (median 640.86 pg/ml vs. 245.46 pg/ml, P ˂ 0.01). Meanwhile, FGF21 ( r = -0.136, P < 0.05) and FGF23 ( r = -0.151, P < 0.05) were both negatively associated with osteoporosis. Moreover, FGF21 ( β = -0.067, P < 0.05) was an independent factor for osteoporosis. Furthermore, FGF21 combined with age yielded a marked specificity (90.5 %) and sensitivity (61.8 %) in predicting osteoporosis of haemodialysis patients with less residual renal function. Conclusions FGF21 has a positive relationship with the incidence of osteoporosis in patients on haemodialysis. FGF21 combined with age is a good predictive biomarker for osteoporosis in patients on haemodialysis, especially those with less residual renal function.

回顾性分析于2018年1月至2019年6月于东南大学附属中大医院肾内科就诊的带隧道带涤纶套导管（tunneled cuffed catheter，TCC）相关中心静脉病变患者，探讨经皮球囊腔内血管成形术（percutaneous transluminal balloon angioplasty，PTA）在中心静脉病变中的临床疗效。结果发现PTA在拔除嵌顿导管以及治疗中心静脉狭窄方面疗效较好，技术成功率100%，具有创伤性小、成功率高、患者耐受性好等优势，增加再置管成功率，是一种安全有效的治疗方法。

目的 探讨应用长期导管血液透析并发导管相关性血流感染的危险因素,并建立相关预测模型.方法 回顾性分析长期静脉置管行血液透析的终末期肾病患者临床资料,对训练组患者并发导管相关性血流感染的危险因素进行Logistic回归分析,利用R语言建立预测模型,并通过验证组对模型预测性能进行验证.结果 导管相关性血流感染的危险因素包括吸烟史、贫血、糖尿病,由此构建的预测模型在训练组和验证组中C指数分别为0.761和0.714.结论 该模型能够有效筛选血液透析患者并发导管相关性血流感染的高危人群.

肾脏病可能会悄悄发生在我们身上,而我们却不自知,很多人发现时就已经发展为尿毒症了.那生活中哪些习惯会损伤我们的肾脏,增加肾脏的负担,影响肾脏健康呢? 不喝水或者喝水少 肾脏是体内调节电解质和酸碱平衡的重要脏器,而肾脏得以正常工作,整个过程必须要有水分.缺乏水分会让尿液浓缩,药物和人体细胞代谢活动产生的废物在肾脏中的浓度升高,肾脏易出现药物蓄积和肾结石.身体缺水会导致肾脏灌注不足,严重者可引起肾功能衰竭.

血液透析是一种不完全的肾脏功能替代,随着患者透析时间的延长,毒素蓄积,会产生各种各样的并发症,严重影响了患者的生活质量和寿命,并且与患者的住院率和死亡率密切相关[1].血液滤过吸附再回输(hemo-filtrate-reinfusion,HFR)是新一代的血液净化技术,应用Supra HFR双腔透析器,串联一个高通量滤器和低通量滤器,联合一支吸附柱,通过对流-吸附-弥散的原理,清除体内毒素.据国外文献报道,HFR对小分子毒素、中分子毒素以及蛋白结合毒素都有较好的清除效果,目前国内应用较少,暂无相关报道.本研究通过对东南大学附属中大医院维持性血液透析(maintenance hemodialysis,MHD)患者,给予HFR治疗,取得了较好的临床疗效,现报道如下.

Background: Dialysis unit blood pressure (BP) pattern showed superiority in prognostic evaluation and interdialytic BP burden assessment. However previous studies mainly focused on the recurrent BP pattern within a session (intradialytic BP change or intradialytic BP slope), the clinical value of the weekly pattern of dialysis unit BP is unknown. Methods: We performed a prospective cohort study in adult end stage renal disease (ESRD) patients on thrice weekly hemodialysis (HD). The slope and the change of the postdialysis systolic BP (SBP) in the course of a week (post‐SBP slope and post‐SBP change) were used to characterize the weekly pattern of dialysis unit BP. Outcomes included all‐cause mortality, cardiovascular mortality, and first cardiovascular event. We also measured the home BP in our cohort. Results: One hundred and twenty‐nine subjects were followed over a median of 31 months. Higher post‐SBP slope (≥0.185) was independently associated with increased risk of all‐cause mortality, cardiovascular mortality, and first cardiovascular event. Results were similar for increased post‐SBP change. HD patients with a higher post‐SBP slope or an increased post‐SBP change also had significant increased interdialytic BP burden measured by home SBP on both dialysis days and non‐dialysis days. Conclusions: Post‐SBP slope and post‐SBP change might be promising dialysis unit BP markers for prognostic evaluation and interdialytic BP burden assessment.

目的观察彩色多普勒超声引导下经皮穿刺腹膜透析置管术的临床应用效果。方法回顾性分析2018年1月至2019年06月于东南大学附属中大医院采用彩色多普勒超声引导下经皮穿刺腹膜透析置管术的终末期肾病患者54例,所有患者均使用Tenchoff双cuff直管,术前彩超定位穿刺位点,术中彩色多普勒超声引导穿刺置管,观察患者穿刺置管的手术相关指标以及术后导管相关并发症。结果 54例患者均成功置入腹膜透析导管,技术成功率100%,手术时间(23.0±4.6)min。所有患者均未出现脏器损伤,术后无需使用镇痛剂。术后至进入持续非卧床腹膜透析的时间为(12.1±5.4)d。术后有4例患者(7.41%)发生导管移位,3例患者(5.56%)出现导管出口渗液。随访期间1例患者出现导管出口感染,无患者出现腹膜炎以及导管阻塞情况。结论彩色多普勒超声引导下经皮穿刺腹膜透析置管术,手术创伤小、操作简单,手术成功率高,术后并发症较少,临床效果好。

Muscle wasting is associated with increased mortality and morbidity in chronic kidney disease (CKD) patients, especially in the haemodialysis (HD) population. Nevertheless, little is known regarding diaphragm dysfunction in HD patients. We conducted a cross-sectional study at the Institute of Nephrology, Southeast University, involving 103 HD patients and 103 healthy volunteers as normal control. Ultrasonography was used to evaluate diaphragmatic function, including diaphragm thickness and excursion during quiet and deep breathing. HD patients showed lower end-inspiration thickness of the diaphragm at total lung capacity (0.386 ± 0.144 cm vs. 0.439 ± 0.134 cm, p < 0.01) and thickening fraction (TF) (0.838 ± 0.618 vs. 1.127 ± 0.757; p < 0.01) compared to controls. The velocity and excursion of the diaphragm were significantly lower in the HD patients during deep breathing (3.686 ± 1.567 cm/s vs. 4.410 ± 1.720 cm/s, p < 0.01; 5.290 ± 2.048 cm vs. 7.232 ± 2.365 cm; p < 0.05). Changes in diaphragm displacement from quiet breathing to deep breathing (△m) were lower in HD patients than in controls (2.608 ± 1.630 vs. 4.628 ± 2.110 cm; p < 0.01). After multivariate adjustment, diaphragmatic excursion during deep breathing was associated with haemoglobin level (regression coefficient = 0.022; p < 0.01). We also found that the incidence of dyspnoea and hiccup and the fatigue scores, all of which were related to diaphragmatic dysfunction, were significantly higher in HD patients than in controls (all p < 0.01). Improving diaphragm function through targeted therapies may positively impact clinical outcomes in HD patients.

自体动静脉内瘘是维持性血液透析患者使用最多的血管通路方式,内瘘流量增加可增加心输出量,导致心脏结构和功能的改变.由于内瘘高流量导致的高输出量心力衰竭是内瘘术后少见的并发症之一.我们报告一例因高流量内瘘致高输出量心力衰竭,并分析其发生机制,寻求最佳治疗方案.环阻法缩窄内瘘是治疗高流量内瘘的可行性方案之一.

Background: Muscle wasting is associated with increased mortality and morbidity in chronic kidney disease (CKD) patients, especially in the haemodialysis (HD) population. Little is known regarding diaphragmatic dysfunction under CKD conditions. Methods: We conducted a cross-sectional study at the Institute of Nephrology, Southeast University, involving 103 HD patients and 103 healthy volunteers as normal control. Ultrasonography was used to evaluate diaphragmatic function, including diaphragm thickness and excursion. We further examined the prevalence of diaphragmatic dysfunction and its influence factor and relationship with debilitating symptoms (dyspnoea, hiccups, and fatigue) in HD patients. Results: HD patients showed lower end-inspiration thickness of the diaphragm at total lung capacity and thickening fraction compared to controls. The velocity and excursion of the diaphragm were significantly lower in the HD patients during deep breathing. Changes in diaphragm displacement from quiet breathing to deep breathing (△m) were lower in HD patients than in controls. After multivariate adjustment, hemoglobin level may have effects on diaphragmatic functions such as diaphragm excursion at total lung capacity (DMTLC) and △m. Diaphragm thickness during deep breathing was positively correlated with weight and was greater in males than in females. We also found that the incidence of dyspnoea and snoring and the fatigue scores, all of which were related to diaphragmatic dysfunction, were significantly higher in HD patients than in controls (all p < 0.01). In addition, diaphragmatic dysfunction was confirmed in a CKD mouse model. Conclusions: Improving diaphragm function through targeted therapies may positively impact clinical outcomes in HD patients.Trial Registration Information: Chinese Clinical Trials Registry, 2018ZDKYSB167. Retrospectively registered on May 18, 2018.Funding Statement: This work was supported by grants from the National Natural Science Foundation of China (81700618), the Natural Science Foundation of Jiangsu Province (BK20181487), the China Young Nephrologist Research Project, and a Southeast University High Level Thesis Project to Bin Wang. It was supported by additional grants from the National Natural Science Foundation of China (81720108007, 81470922, 31671194, 81720108007, and 81670696), the National Key Research Programme (2018YFC130046, 2018YFC1314000) and the Clinic Research Center of Jiangsu Province (BL2014080) to Bi-cheng Liu.Declaration of Interests: None of the authors has any conflict of interest to declare.Ethics Approval Statement: The study protocol was approved by the Ethics Committee of Zhongda Hospital affiliated to Southeast University. The details of the study were explained to each patient; if he or she agreed to participate, a written informed consent was signed.

目的:探讨他克莫司联合糖皮质激素治疗原发性肾病综合征的疗效、疗效相关因素,以及治疗过程中不良事件的发生情况.方法:收集使用他克莫司联合糖皮质激素治疗的原发性肾病综合征患者62例的临床资料,观察疗效,分析疗效相关因素及不良事件发生率.结果:经治疗部分缓解者21例(33.9％),完全缓解者20例(32.2％);用药前天门冬氨酸氨基转移酶(AST)水平(OR 1.193,95％ CI 1.041 ～ 1.368,P=0.011)为缓解的相关因素,他克莫司血药浓度(OR 1.492,95％ CI 1.025 ～2.173,P=0.037)以及是否伴有血尿(OR 0.173,95％ CI 0.04 ～0.737,P=0.018)是完全缓解的相关因素;IgM肾病患者在治疗后均获得缓解;肝功能损伤、肾功能损伤、糖尿病、感染的发生率分别为19％、16％、16％和18％.结论:激素联合他克莫司治疗原发性肾病综合征临床缓解率高,主要副作用为肝肾功能损伤、血糖增高和感染.